Scaffold and method for implanting cells

ABSTRACT

An improved method of implanting cells in the body of a patient includes positioning viable cells on a support structure. One or more blood vessels may be connected with the support structure to provide a flow of blood through the support structure. A support structure may be positioned at any desired location in a patient&#39;s body. The support structure may be configured to replace an entire organ or a portion of an organ. An organ or portion of an organ may be removed from a body cells and/or other tissue is removed to leave a collagen matrix support structure having a configuration corresponding to the configuration of the organ or portion of an organ. Alternatively, a synthetic support structure may be formed. The synthetic support structure may have a configuration corresponding to a configuration of an entire organ or only a portion of an organ.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The benefit of Provisional Application No. 60/387,013, filed Jun.7, 2002, is claimed under 35 U.S.C. §119(e).

BACKGROUND OF THE INVENTION

[0002] The present invention relates to the implanting of cells into abody of a patient, and in particular to the implantation of viable cellson a scaffold or support structure.

[0003] Various organs or other tissue in a patient's body may becomedefective due to trauma, disease, or other causes. Transplanting oforgans and/or tissue has been utilized for the treatment of defectiveorgans. However, problems have been encountered in securing an adequatenumber of suitable donor organs. It is believed that it may be desirableto have a patient grow a replacement organ, portion of an organ, orother body tissue for replacement of any defective tissue, organ, orportion thereof.

SUMMARY OF THE INVENTION

[0004] The present invention relates to a method of implanting viablecells into a body of a patient. The viable cells may be positioned on asupport structure. One or more blood vessels in a patient's body may beconnected with the support structure at one or more locations. Theviable cells on the support structure may be exposed to blood flow inthe support structure. One or more support structures may be providedand positioned in the patient's body.

[0005] The support structure may be formed in many different ways. Oneway in which the support structure may be formed is by removing an organor a portion of an organ from a body, either the patient's own body oranother body. Cells and/or other tissue may be removed from the organ orportion of an organ to leave a collagen matrix support structure havinga configuration corresponding to the configuration of the organ orportion of an organ. Viable cells are positioned on the collagen matrixsupport structure. The support structure, which has a configurationcorresponding to the configuration of an organ or portion of an organ,is positioned in the patient's body with the viable cells disposed onthe support structure. Blood vessels may be connected with the supportstructure as it is positioned in the patient's body.

[0006] The support structure may be formed by using an organ or portionof an organ from a body that is either the patient's body or anotherbody as a pattern. Alternatively, the pattern may be syntheticallyconstructed to have a configuration corresponding to the generalconfiguration of an organ or portion of an organ in a patient's body.The pattern may be at least partially enclosed with mold material. Thepattern and mold material are subsequently separated to leave a moldcavity. The synthetic support structure is subsequently shaped in themold cavity. The synthetic support structure may be formed as a unitarymember or formed by one or more intertwined strands.

[0007] One or more expandable members may be utilized to align animplant and tissue in a patient's body. For example, one or moreballoons may be utilized to align a portion of a blood vessel with asegment which is to be implanted into the blood vessel.

[0008] It should be understood that the present invention has aplurality of different features which may be utilized separately or invarious combinations. It is also contemplated that the various featuresof the invention may be utilized with known features from the prior art.Although specific combinations of features have been described herein,it is contemplated that other combinations of features will be apparentto those skilled in the art and will be formed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The foregoing and other features of the invention will becomemore apparent upon a consideration of the following description taken inconnection with the accompanying drawings wherein:

[0010]FIG. 1 is a schematic illustration depicting the manner in which asupport structure is connected with portions of one or more bloodvessels in a patient's body;

[0011]FIG. 2 is a fragmentary schematic plan view, taken generally alongthe line 2-2 of FIG. 1, illustrating in the manner in which viable cellsmay be positioned on the support structure of FIG. 1 and exposed to aflow of blood through the support structure;

[0012]FIG. 3 is a schematic illustration, generally similar to FIG. 2,illustrating in the manner in which a barrier may be used to direct theflow of blood through a support structure;

[0013]FIG. 4 is a fragmentary schematic sectional view, generallysimilar to FIG. 3, depicting the manner in which a plurality of bloodvessels are connected with a support structure containing a barrier todirect a flow of blood through the support structure and to disperse theflow of blood in the support structure;

[0014]FIG. 5 is a schematic illustration of an organ, that is, a kidney,in a patient's body;

[0015]FIG. 6 is a schematic illustration depicting the manner in which aplurality of the support structures of FIGS. 1-4 may be positioned inthe organ of FIG. 5;

[0016]FIG. 7 is a schematic illustration depicting the manner in whichan organ or model of an organ may be used as a pattern to form a moldcavity in which a synthetic support structure may be formed;

[0017]FIG. 8 is a schematic illustration depicting the manner in which asupport structure on which viable cells are disposed is utilized toreplace a portion of a blood vessel;

[0018]FIG. 9 is a schematic illustration depicting the manner in which aballoon is utilized to align the support structure and portions of ablood vessel;

[0019]FIG. 10 is a schematic illustration, generally similar to FIG. 9,illustrating the manner in which a plurality of balloons may be utilizedto align the support structure and portions of a blood vessel;

[0020]FIG. 11 is a top view of an embodiment of a support structure inthe form of a three dimensional mesh of fibers.

DESCRIPTION OF SPECIFIC PREFERRED EMBODIMENTS OF THE INVENTION GeneralDescription

[0021] An implant 20 is illustrated schematically in FIGS. 1 and 2. Theimplant 20 includes a support structure or matrix 22 (FIG. 2) which mayhave any desired configuration. A plurality of viable cells 24 (FIG. 2)are positioned on the support structure 22. Although the supportstructure 22 has been illustrated schematically in FIGS. 1 and 2 ashaving a rectangular configuration and the viable cells 24 have beenillustrated schematically as being disposed in a rectangular array on arectangular matrix, it is contemplated that the support structure 22could have any desired configuration and that the viable cells 24 couldbe disposed in any desired arrangement on the support structure.

[0022] In accordance with one of the features of the present invention,one or more blood vessels 28 are connected with the support structure 22to provide for a flow of blood through the support structure. Althoughthe support structure 22 may be connected with blood vessels 28 in manydifferent ways, in the specific arrangement illustrated in FIGS. 1 and2, an arteriole (a small artery) 32 and a venule (small vein) 34 areconnected with the support structure 22. This results in a flow of bloodfrom left to right, as indicated by arrows in FIGS. 1 and 2, through theimplant 20. The viable cells 24 are exposed to the flow of blood.

[0023] Although the implant 20 has been illustrated in FIGS. 1 and 2 asbeing connected with an artery 32 and vein 34, it is contemplated thatthe implant 20 could be connected with one or more arteries or one ormore veins. Thus, a portion of the same artery or vein may be connectedwith opposite sides of the implant 20. Alternatively, a portion of oneartery or vein may be connected with one side of the implant 20 and aportion of another artery or vein may be connected with the oppositeside of the implant.

[0024] If desired, a plurality of portions of arteries and/or veins maybe connected with one side of the implant 20. Similarly, a plurality ofportions of arteries and/or veins may be connected with the oppositeside of the implant 20. The number of portions of arteries and/or veinsconnected with the implant 20 will vary depending upon the locationwhere implant 20 is to be positioned in a patient's body. The patient isa living human.

[0025] The interior of the support structure 20 has a plurality ofpassages through which blood may flow. It is contemplated thatcapillaries, arterioles, and/or venules may grow in the supportstructure 20. The outer sides of the support structure 20 may be formedof a material which is impervious to blood or a material which restrictsthe flow of blood from the implant 20 to surrounding tissue.

[0026] The implant 20 may be positioned at any desired location in apatient's body. For example, the support structure 22 may be positionedin an organ, that is, a functional unit of cells. The organ in which thesupport structure 22 is positioned may be a heart, blood vessel, brain,intestine, stomach, adrenal gland, liver, pancreas, skeleton, spinalcord, or other organ. The support structure 22 may be positioned ineither soft tissue or hard tissue.

[0027] The support structure 22 may have a configuration correspondingto the configuration of an entire organ or a portion of an organ. If thesupport structure 22 has a configuration corresponding to theconfiguration of a portion of an organ, a plurality of the supportstructures 22 may be positioned in an organ. The support structures 22may be positioned adjacent to each other and/or spaced apart from eachother in the organ. Although it may be desired to position the supportstructure 22 in an organ, the support structure may be positioned atother locations in a patient's body.

[0028] The support structure 22 may be positioned in a patient's body byfiber optic surgery, such as arthroscopic or laproscopic surgery. It iscontemplated that an imaging apparatus and/or a robotic mechanism may beused in positioning the support structure. This may include moving thesupport structure through a cannula in the manner disclosed in U.S.patent application Ser. No. 10/102,413 filed Mar. 20, 2002 by Peter M.Bonutti and entitled Methods of Securing Body Tissue. The implant 20 maybe connected with tissue in a patient's body in any one of the waysdisclosed in the aforementioned application Ser. No. 10/102,413, whichis incorporated herein.

[0029] The support structure 22 may be formed in many different ways andof many different materials. The specific manner in which the supportstructure 22 is formed will be influenced, to some extent at least, bythe location at which the support structure is to be positioned in thepatient's body. In addition, the manner in which the support structureis formed will depend upon the overall size of the support structure andwhether or not it is to be formed of biodegradable or nonbiodegradablematerial.

[0030] The support structure 22 may be integrally formed as one pieceand have a porous construction with openings in which viable cells 24are positioned. Alternatively and as shown in FIG. 11, the supportstructure may be formed by intertwining one or more strands (filaments)of a desired material. The viable cells 24 will be positioned inopenings disposed between the intertwined strands.

[0031] The support structure 22 may be formed of a hydrophilic materialwhich absorbs body fluid when the support structure 22 is positioned ina patient's body. When the support structure absorbs body fluid, itexpands and presses against adjacent body tissues to promote theformation of a mechanical interlock between the support structure 22 andadjacent body tissues. As the hydrophilic material of the supportstructure absorbs liquid from the patient's body, the volume of thesupport structure 22 increases. The resulting expansion of the supportstructure 22 presses the support structure against adjacent body tissue.As this occurs, the material of the support structure 22 and theadjacent tissue are pressed firmly against each other to form aconnection between the support structure and the adjacent tissues.

[0032] The formation of a mechanical interlock may also be promoted bycompressing the support structure 22 before insertion of the supportstructure into the patient's body. When this is done, the supportstructure forms a mechanical interlock with tissue due to the combinedeffects of absorbing fluid and resiliently expanding.

[0033] The support structure 22 may be formed of a polymeric materialwhich absorbs body liquid. The polymeric material may be either acopolymer or a dipolymer. The polymeric material may be natural orsynthetic collagen. If desired, the polymeric material may be cellulose,petroylglutamic acid, high purity carboxymethylcellulose, orpolylactide. Of course, the support structure 22 may be formed of otherknow material which absorbs body liquid. The support structure 22 may beformed of materials disclosed in U.S. Pat. No. 6,152,949 and form aninterlock with adjacent body tissues in the manner disclosed in thatpatent.

[0034] The implant 20 may be formed as an entire organ or as a portionof an organ. When this is the situation, the support structure 22 may beformed by removing an entire organ or a portion of an organ from a body.The body from which the organ is removed may be either the patient'sbody or another body.

[0035] Once the entire organ or portion of an organ has been removedfrom a body, cells and/or other tissue may be removed from the organ toleave a support structure 22 having a configuration corresponding to theconfiguration of the organ or portion of an organ. The support structure22 may include a collagen matrix formed by tissue of the organ orportion of an organ removed from a body.

[0036] Rather than using an organ or a portion of an organ removed froma body to form the support structure 22, the organ or portion of anorgan may be used as a pattern in the formation of a synthetic supportstructure. The synthetic support structure 22 may be eitherbiodegradable or nonbiodegradable. The synthetic support structure 22may be molded or woven to have a configuration corresponding to theconfiguration of the organ or portion of an organ. It is contemplatedthat the synthetic support structure 22 may have a compositeconstruction and be formed of different materials which have differentcharacteristics.

[0037] It is contemplated that the viable cells 24 may be any desiredtype of viable cells. It is contemplated that the viable cells 24 maycorrespond to cells which were in a damaged organ or other portion of apatient's body. More than one type of viable cell 24 may be positionedon the same support structure 22. The support structure 22 and viablecells 24 may be positioned in either hard or soft tissue.

[0038] When the support structure 22 is to be positioned in an organ, itis contemplated that the viable cells 24 on the support structure 22will have characteristics associated with the characteristics of normalcells in the organ in which the support structure is to be positioned.Many organs contain cells which have different characteristics andperform different functions within the organ. It is contemplated thatthe viable cells 24 on the support structure 22 may have differentcharacteristics corresponding to the different characteristics of cellsof an organ. When the support structure 22 is to be positioned outsideof an organ, the cells positioned on the support structure may have anydesired characteristic or combination of characteristics.

[0039] It is also contemplated that the viable cells can be pluripotentcells that are directed to differentiate into the desired cell type ortypes. One example of such cells is stem cells. The differentiation canbe controlled by applying or exposing the cells to certain environmentalconditions such as mechanical forces (static or dynamic), chemicalstimuli (e.g. pH), and/or electromagnetic stimuli.

[0040] More than one type of cell may be positioned on the supportstructure 22. The type of cell positioned at a particular location onthe support structure 22 will be determined by the orientation of thesupport structure in a patient's body and by the specific type of tissuedesired at a particular location in a patient's body. For example,stromal cells may be positioned at a location where foundation tissue isdesired and another type of cell may be positioned at locations where itis desired to have tissue perform a special function.

[0041] As previously noted, the present invention envisions harvestingand culturing cells prior to placement within the support structure 22.Although most researchers tend to isolate and grow one basic cell line,it may be beneficial to mix multiple different cell lines together. Forexample, embryonic cells or fetal cells can be used to grow cartilage orany desired tissue (such as liver or pancreas) and these can be combinedwith the mature cells of an older individual. The older individual caneither be the patient receiving the mixed cells or possibly anotherhealthier individual. Regardless of the source, the net result is acombination of two cell populations, one younger and more vibrant andanother which is older, more mature. The younger cells may have more ofan ability to differentiate into the desired cell type, while the oldercells may have more of the regulatory factors, tissue inductive factors,etc, which would be more likely to guide and control the younger cells.

[0042] Growth factors or other therapeutic agents can be added to eitheror both of the cell types. The addition of the agents can be beforeand/or after combining the cells. Examples of growth factors that can beused include insulin-like growth factor (IGF-1), fibroblast growthfactor (FGF), transforming growth factor (TGF-β), hepatocyte growthfactor (HGF), platelet-derived growth factor (PDGF), Indian Hedgehog(Inh) and parathyroid hormone-related peptide (PTHrP), bonemorphogenetic proteins (BMPs), and Interleukin-1 receptor antagonist(IL-1ra).

[0043] There are many different types of cells which may be positionedon the support structure 22. These cells include progenitor cells whichdifferentiate and proliferate to form cells having desiredcharacteristics; stromal cells which relate to foundation supportingtissue; and mesenchymal cells which relate to connective tissues, bloodand blood vessels, and other systems. Fibroblasts may be used in theproduction of connective tissues. Osteoblasts may be used in theproduction of hard tissue (bone). Myoblasts may be used in theproduction of muscle.

[0044] Specific cells may be used to provide for growth of tissue havinga function associated with the cell. These cells may include reticularcells, smooth muscle cells, chondrocytes, retinal cells, endothelialcells, and other known cells.

[0045] For example, if cardiac tissue is desired, the cells can includeendocardial, myocardial, and pericardial cells. These cells can belayered or otherwise arranged. If cartilage and bone tissue is desired,a combination of chondrocytes (and/or chondroblasts) and osteoblasts, ortheir precursors can be used.

[0046] One source of precursor cells is bone marrow, which containprogenitor cells. These progenitor or stem cells can be treated so as todifferentiate into any desired cell type.

[0047] Although the present invention anticipates that the cells can beharvested in any desired fashion, and are accordingly not discussed indetail herein, the harvesting of fetal cells deserves special note.Fetal cells can be harvested directly from the fetus in situ usingminimally invasive techniques or through procedures such asamniocentesis, chorionic villus sampling (CVS), and other similarmethods that do not involve invasive contact with the fetus. Regardlessof the harvesting method, image guidance (MRI guidance, ultrasonicguidance, etc) can be used. Computer assisted techniques can be used inconjunction with the image guidance. Additionally, the harvesting can beperformed using a robotic or haptic system.

[0048] If desired, specific types of fetal cells such as liver,pancreas, or renal cells, etc, could be selectively harvested. The fetusdoes not necessarily have to be harmed during the harvesting, but can bekept viable. Thus, the fetus does not have to be aborted after obtainingthe cells, but actually could be left alive and could be a source forcells possibly through one or multiple aspirations while the fetus isstill growing. For example, one may require multiple aspirations ofliver cells or neural cells, with multiple cell types at various levelsof maturation for the desired graft.

Implant

[0049] The implant 20 includes the support structure 22 on which theviable cells 24 are disposed. The viable cells 24 are exposed to a flowof blood between the blood vessels 32 and 34. The blood vessels 32 and34 are connected with the support structure 22. The blood flows throughthe blood vessels 32 and 34 in the manner indicated by arrows in FIGS. 1and 2.

[0050] It is contemplated that the blood vessels 32 and 34 may beconnected with a support structure 22 in any desired manner. In thespecific embodiment illustrated schematically in FIGS. 1 and 2, an endportion of the arteriole 32 is stitched to the support structure 22.Similarly, an end portion of the venule 34 is stitched to the supportstructure 22. In addition to being connected with the blood vessels 28,the implant 20 may be retained in tissue in a patient's body bystitching the support structure 22 to the tissue in the patient's body.

[0051] It is contemplated that the blood vessels 28 may be connectedwith the support structure in many different ways. For example, thearteriole 32 may be connected with the support structure 22 by anadhesive such as cyanoacrylate (so-called “superglue”), Polylatic acid,or fibrin. Additionally, the modified biofilm discussed below inconnection with the attachment of cells to the support structure 22 canbe used to couple the arteriole 32 and the support structure 22. Ofcourse, the end portion of the venule 34 may be connected with thesupport structure 22 by an adhesive in the same manner as in which thearteriole 32 is connected with the support structure. It should beunderstood that the blood vessels 32 and 34 could both be arterioles orvenules if desired.

[0052] To facilitate connecting the arteriole 32 and venule 34 with thesupport structure 22, appropriately shaped and sized recesses may beprovided in the support structure 22. These recesses would have aninside dimension which is only slightly larger than the outside diameterof the arteriole 32 and/or venule 34. The arteriole 32, for example,would be telescopically inserted into the cylindrical recess in thesupport structure 22. The joint between the support structure and theexterior surface of the arteriole 32 may be sealed with a suitablesealant. It is contemplated that an adhesive could be utilized as thesealant.

[0053] In the embodiment illustrated in FIGS. 1 and 2 the arteriole 32and venule 34 are shown as being axially aligned with each other, thatis, they are in a coaxial relationship. However, it is contemplated thatthe arteriole 32 could be offset to one side, for example, to the left,and the venule 34 offset to the opposite side, for example, to theright, of the central axis of the support structure 32. This wouldpromote a dispersion of the flow of blood from the arteriole in thesupport structure 22 before the flow of blood entered the venule 34. Ofcourse, this would increase the exposure of the viable cells 24 to theflow of blood.

[0054] If desired, the arteriole 32 could be inserted for a substantialdistance, into the support structure 22 and the venule 34 inserted for asubstantial distance into the support structure 22. If this was done, itis contemplated that the arteriole 32 would be offset from the venule34. Thus, the arteriole 32 could be offset downward (as viewed in FIG.2) and the venule 34 offset upward (as viewed in FIG. 2) so that theyare not in axial alignment with each other.

[0055] By telescopically inserting the arteriole 32 into a cylindricalrecess or hole in the support structure 22 for a distance which is morethan one half of the thickness of the support structure, the flow ofblood would exit the arteriole adjacent to the side of the supportstructure from which the venule 34 extends, that is, the right side ofthe support structure 22 (as viewed in FIG. 2). Similarly, the venule 34would extend telescopically into a recess which extends past the centerof the support structure 22. This would result in the flow of blood inthe support structure 22 entering the venule 34 adjacent to the left (asviewed in FIG. 2) side of the support structure 22.

[0056] If this was done, the arteriole 32 and venule 34 would not beaxially aligned with each other but would be offset so that the bloodwould flow from the arteriole 32 in a reverse direction, that is towardthe left as viewed in FIG. 2, to the entrance to the venule 34. Thiswould result in the arteriole 32 and venule 34 being disposed in aside-by-side and offset relationship relative to each other in thesupport structure 22. The blood would flow from the end of the arteriole32 adjacent to the right (as viewed in FIG. 2) side of the supportstructure 22 to the end of the venule 34 adjacent to the left (as viewedin FIG. 2) side of the support structure. The resulting nonlinear flowof blood between the arteriole 32 and venule 34 would promote dispersionof the blood in the support structure 22 and promote exposure of theviable cells 24 to the flow of blood.

[0057] In the embodiment illustrated in FIGS. 1 and 2 the arteriole 32and venule 34 are connected directly to the support structure 22.However, it is contemplated that the support structure 22 could beprovided with a pair of conduits which are connected between an arteryand vein in a patient's body. Thus, the support structure 22 may beprovided with a tubular conduit in place of the arteriole 32 of FIGS. 1and 2 and a tubular conduit in place of the venule 34. The tubularconduit which replaces the arteriole 32 would be connected with anartery in the patient's body and the tubular conduit which replaces thevenule 34 would be connected with a vein in the patient's body. Thetubular conduits which extend from the support structure 22 may beformed of a synthetic material or may be formed by veins and/or arteriesharvested from the patient's body or from another body.

[0058] A plurality of support structures 22 may be implanted into apatient's body. If this is done, the plurality of support structures 22may be interconnected by conduits before being placed in the patient'sbody. The plurality of the support structures 22 may be interconnectedto have parallel and/or series flow of blood through the supportstructures 22.

[0059] It is contemplated that feeder conduits could extend from amanifold conduit to conduct a flow of blood to each support structure 22of a plurality of support structures. If this is done, a secondplurality of feeder conduits may extend from a second manifold conduitto each of the support structures to conduct a flow of blood from theplurality of support structures. The first manifold conduit may beconnected in fluid communication with an artery in a patient's body andthe second manifold conduit may be connected with a vein in a patient'sbody. This would enable a plurality of support structures 22 to besupplied with blood conducted from a single connection between the firstmanifold conduit and an artery. Similarly, blood would flow from theplurality of support structures 22 to a vein through a single connectionbetween a vein and the second manifold conduit. If desired, the firstand second manifold conduits could both be connected with either anartery or a vein.

[0060] It is believed that interconnecting a plurality of supportstructures 22 with suitable conduits before the support structures arepositioned in a patient's body will facilitate positioning of thesupport structures. This is because the number of connections which haveto be made between the support structures 22 and the blood vessels inthe patient's body would be minimized. When a plurality of supportstructure are utilized they may be interconnected in a parallel bloodflow arrangement in the manner previously described or in a series bloodflow arrangement before being positioned in the patient's body.

[0061] It is contemplated that the sides of the support structure 22 maybe constructed as to retard a flow of blood from the support structure.Thus, the support structure 22 may be constructed with outer sidesurfaces that effectively block a flow of blood from the supportstructure through the outer side surfaces of the support structure.Alternatively, the outer sides of the support structure 22 may beprovided with very small openings which effectively retard, withoutcompletely blocking, a flow of blood through the sides of the supportstructure. In another embodiment, the sides of the support material 22are made of a material that has one-way permeability. This would eitherallow absorption of blood while preventing discharge, or allow blooddischarge while preventing absorption.

[0062] If the side walls 40 are effective to block the flow of bloodfrom the support structure 22, all of the blood which enters the supportstructure 22 from the arteriole 32 (FIGS. 1 and 2) would flow from thesupport structure through the venule 34. However, if the side walls 40are somewhat porous so that they are effective to retard or onlypartially block a flow of blood through the side walls 40, a portion ofthe blood from the arteriole 32 would flow from the support structure 22through the side walls 40 of the support structure while the remainderof the blood from the arteriole 32 would flow from the support structurethrough the venule 34. By allowing some, but not all, of the blood toflow from the support structure 22 through the side walls 40, dispersionof blood within the support structure is promoted.

[0063] It is contemplated that minute passages may be provided in thesupport structure 22 to accommodate the growth of capillaries within thesupport structure. Thus, a network or web of capillaries may grow in thesupport structure 22 between the arteriole 32 and venule 34. Thisnetwork of capillaries would facilitate supplying blood to all of theviable cells 24 within the support structure 22. The side walls 40(FIG. 1) of the support structure 22 may have small openings throughwhich capillaries grow between the support structure and surroundingtissue in the patient's body.

[0064] In the embodiment of the invention illustrated in FIGS. 1 and 2,a single arteriole 32 is connected with a support structure 22 toconduct blood to the support structure and a single venule 34 isconnected with the support structure to conduct blood from the supportstructure. It is contemplated that a plurality of arterioles 32 and/orvenules 34 may be connected with the support structure 22. Thus, aplurality of arterioles 32 may be connected with a first side wall 40 ofthe support structure 22 to conduct a flow of blood into the supportstructure at a plurality of locations. Similarly, a plurality of venules34 may be connected with a second side wall 40 of the support structure22 at a plurality of locations to conduct blood from the supportstructure. The number of arterioles 32 connected with the supportstructure 22 may be the same as, greater than, or less than the numberof venules 34 connected with the support structure.

[0065] When it is desired to conduct blood to and from the supportstructure 22 along a plurality of flow paths, it is believed that it maybe desired to connect a plurality of conduits with the support structurebefore the support structure is positioned in the patient's body. Thus,at a location remote from an operating room, a plurality of conduits maybe connected with one of the side walls 40 of the support structure 22.These conduits may all be connected with a single relatively largeconduit. This relatively large conduit would be connected with an arteryin a patient's body in an operating room. Similarly, a plurality ofconduits may be connected with a second side wall of the supportstructure 22 and be connected with a second single conduit. This singleconduit may be connected with a vein in a patient's body in an operatingroom. This would minimize the number of connections which would have tobe made with the support structure 22 during a surgical procedure in anoperating room and would enable most of the connections to be made in aless stressful environment remote from the operating room.

[0066] Tissue inductive growth factors and/or other therapeutic agentsmay be provided on the support structure 22 to promote a growth oftissue between the patient's body and the support structure 22. Thetissue growth inductive factors may promote a growth of blood vessels,such as capillaries, between tissue and the patient's body and thesupport structure 22. The tissue inductive growth factors may alsopromote the growth of connective tissue between the support structure 22and the tissue in the patient's body to securely connect the supportstructure in place in the patient's body.

[0067] Other additives include materials such as plasticizers, citrateesters, hexametholsebacate, antibiotics (e.g., tetracyclines,penicillins, mefronidazole, clindamycin, etc.), to prevent infection,etc., or to accomplish other desired conditions or results. Additionaladditives or therapeutic agents include osteoinductive, biocidal, oranti-infection substances. Suitable osteoinductive substances include,for example, growth factors. The growth factors may be selected from thegroup of IGF (insulin-like growth factors), TGF (transforming growthfactors), FGB (fibroblast growth factors), EGF (epidermal growthfactors), BMP (bone morphogenic proteins), and PDGF (platelet-derivedgrowth factors).

[0068] The therapeutic agent(s) may be contained within the material ofthe support structure 22. Alternatively, the agent(s) may be disposed ina structure which is separate from the support structure 22. Forexample, tissue inductive growth factors could be disposed in a collagensponge which is positioned adjacent to the support structure 22 in thepatient's body. Alternatively, the agent(s) may be positioned in astructure which is connected to the support structure 22.

[0069] It is believed that it may be advantageous to have a slow releaseof the agent(s) adjacent to the patient's body tissue and the viablecells 24. The agent(s) could be held in a biodegradable container orcontainers which degrade over a period of time and slowly release theagent(s).

[0070] In order to promote the attachment of the viable cells to thesupport structure 22, the support structure 22 can be pretreated with anagent that promotes cell adhesion. One such agent is an organicsubstance based on a biofilm. A biofilm is a slimy, glue-like substancethat forms when bacteria attach to surfaces exposed to water. Typically,colonies of biofilm bacteria are unwanted as they carry out a variety ofdetrimental reactions. However, a sterile biofilm may be used to promoteinitial attachment of cells to the support structure 22.

[0071] The sterile biofilm could be engineered to isolate the glue-likesubstance while eliminating the adverse properties of the bacteria. Theresulting sterile glue-like substance would be used to help the cellsstick to the support structure 22. The engineered biofilm could be addedto the support structure 22 in the laboratory that produces the supportstructure or just prior to the addition of the cells by the user.Alternatively, the biofilm and support structure could be combinedintra-corporally.

[0072] This biofilm also could be used as an independent polysaccharidebased adhesive with mild to moderate adhesion forces. The biofilm couldserve as a surgical adhesion or grouting for cells, for tissue fixation(soft tissue to soft tissue, soft tissue to bone, etc.) and as asealant.

[0073] In addition to coating the support structure 22, the biofilmcould be used in conjunction with other implants and devices. Forexample, the biofilm could be used to coat a stent. Although the biofilmmight degrade in vivo, the coating could serve as a top coat covering alayer of a therapeutic agent or be impregnated with the therapeuticagent. Thus, as the coating dissolves, the agent is delivered locally ina time-released fashion.

[0074] It is contemplated that the support structure 22 may be formed ofa biodegradable material. The biodegradable material would at leastpartially degrade after the patient's body tissue has grown into thesupport structure 22. The support structure 22 may be formed of aplurality of materials. Some of these materials may be biodegradable andsome of the materials may not be biodegradable. But by forming thesupport structure 22 as a composite of both biodegradable andnonbiodegradable materials, a portion of the support structure woulddegrade with passage of time while another portion of the supportstructure would remain.

[0075] When the support structure 22 is formed entirely of biodegradablematerials, it is contemplated that portions of the structure may degradebefore other portions. Thus, one portion of the support structure 22 maybe formed of material which degrades over a relatively long period oftime while other portions of the support structure 22 may be formed ofmaterials which degrade over a shorter period of time. The provision oftissue inductive growth factors on the support structure would promotethe growth of tissue into the support structure during the degradationof material of the support structure.

[0076] It is contemplated that the support structure 22 may berelatively large and provide for growth of a substantial volume oftissue in a patient's body. Alternatively, the support structure 22 maybe relatively small. If a relatively small support structure 22 isutilized, it is believed that a plurality of the support structures maybe positioned in a patient's body. The individual support structures ofthe plurality of support structures may be positioned adjacent to eachother or spaced apart from each other.

[0077] When the implant 20 is to be positioned relative to the bodytissue, the implant may be moved through a cannula, such as theexpandable cannula disclosed in U.S. Pat. No. 6,338,730, into the bodytissue. An opening for the support structure 22 may be formed in thebody tissue utilizing minimally invasive surgical techniques similar tothose disclosed in U.S. Pat. No. 6,174,313. The surgical techniques mayinvolve moving one or more devices through an expandable cannula intothe body tissue. The devices moved into the patient's body may be guidedby using magnetic resonance imaging systems, ultrasonic imagingapparatus, fluoroscopic apparatus and/or other imaging techniques. Thefluoroscopic apparatus may have a construction similar to that disclosedin U.S. Pat. Nos. 5,099,859; 5,772,594; 6,118,845 and/or 6,198,794. Aplurality of endoscopes may be utilized to generate stereoscopic images,that is, three dimensional images, of an area where the implant 20 is tobe positioned. The endoscopes and other imaging devices may be utilizedin a manner which is the same as is disclosed in U.S. patent applicationSer. No. 10/102,413 filed Mar. 20, 2002 by Peter M. Bonutti and entitledMethod of Securing Body Tissue.

[0078] During the performance of surgical procedures, a drapery systemwhich extends between the patient and the surgeon may be utilized. Thedrapery system may include a drape which is either integrally formed asone piece with a surgeon's gown or is formed separately from thesurgeon's gown and is connected with the surgeon's gown. The draperysystem maintains a sterile field which extends from the surgeon to spaceadjacent to the patient. This enables the surgeon to move relative tothe patient without contaminating the sterile field. The drapery systemmay be constructed in the manner disclosed in U.S. patent applicationSer. No. 10/263,893 filed Oct. 3, 2002 by Peter M. Bonutti and entitledSurgical Draping System.

[0079] If a plurality of relatively small support structures 22 are tobe positioned in a patient's body, it is believed that it may be desiredto interconnect the plurality of support structures with a network ofconduits prior to insertion of the support structures into the patient'sbody. Thus, a relatively large number of support structures 22 may beinterconnected by a web of conduits. The resulting mesh or networkformed of the plurality of small support structures 22 and conduits maybe loosely positioned over soft tissue in a patient's body. Each of thesupport structures 22 may then be individually implanted or moved intosoft body tissue. The webbing of conduits would extend between theindividual support structures 22. The webbing of conduits would then beconnected with the patient's vascular system.

[0080] By having a relatively large number of small support structures22 interconnected by a webbing or network of conduits before the supportstructures are positioned relative to a patient's body, the number ofconnections to the patient's vascular system for a relatively largenumber of support structures would be minimized. The webbing or networkof support structures 22 would be anchored in the patient's body tissueat each location where a support structure was implanted. The webbing ofconduits would be effective to conduct a flow of blood to and from thevarious support structures 22 in the network.

[0081] As previously discussed, it should be understood that the viablecells 24 in the plurality of support structures 22 interconnected by thenetwork of blood conduits may be the same type of cells or differenttypes of cells. It is believed that it may be particularly advantageousto have different types of cells in at least some of the supportstructures 22. For example, one of the support structures 22 may containviable endocrine cells and another support structure may contain viablestromal cells. Still another support structure may contain viableendothelial cells.

[0082] It should also be understood that a plurality of different typesof cells may be provided in a single support structure 22. Thus, viableendocrine cells, viable stromal cells, and viable endothelial cells mayall be provided in one support structure 22 of the plurality of supportstructures interconnected by a network of conduits which conduct bloodto the support structures.

[0083] It is contemplated that the support structure 22 may beconfigured so as to provide for the positioning of a layer of viablecells 28 in a patient's body. The viable cells may be allograftmesenchymal cells and/or stem cells.

Blood Flow

[0084] In the embodiment of the invention illustrated in FIGS. 1 and 2,the flow of blood is conducted from the arteriole 32 to the supportstructure 22 and from the support structure to the venule 34. Thesupport structure 22 contains a matrix of viable cells 24 (FIG. 2). Inthe embodiment of the invention illustrated in FIG. 3, blood flow withinthe support structure 22 is controlled to maximize the exposure of theviable cells 24 to the flow of blood.

[0085] In the embodiment of the invention illustrated in FIG. 3, animplant 20 includes a support structure 22. Blood vessels 28 areconnected with the support structure 22. The blood vessels 28 include anarteriole 32 and a venule 34. In the embodiment of FIG. 3, the arteriole32 and venule 34 are connected to the same side wall 40 of the implant20. In order to maximize exposure of the viable cells 24 to a flow ofblood, a barrier 48 (FIG. 3) is provided in the support structure 22.The barrier 48 is effective to direct the flow of blood in the supportstructure 22. The barrier 48 may extend between and be connected withopposite side walls 40 of the support structure 22. Alternatively, thebarrier 48 may be spaced from the side walls of the support structure.

[0086] It is contemplated that the barrier 48 may be formed of either amaterial which is impervious to a flow of blood or a material havingsmall openings through which blood can flow. If the barrier 48 isprovided with small openings through which blood can flow, the openingswould be small enough to retard a flow of blood through the barrier. Itis contemplated that barrier 48 may be integrally formed as one piecewith a support structure 22 or formed separately from the supportstructure and mounted in the support structure.

[0087] The flow of blood from the arteriole 32 cannot readily moveupward (as viewed in FIG. 3) through the barrier 48. Therefore, theblood will flow downward towards the viable cells 24 in the lowerportion of the support structure 22. The blood from the arteriole 32will subsequently flow upward from the lower portion of the supportstructure toward the upper portion of the support structure. When theblood is has moved around the right (as viewed in FIG. 3) end of thebarrier 48, the blood can flow upward through the upper portion of thesupport structure 22. The upper portion of the support structure 22 isconnected with the venule 34 which conducts the flow of blood from thesupport structure 22 to a vein.

[0088] With the specific arrangement of the barrier 48, arteriole 32 andvenule 34 illustrated in FIG. 3, it is believed that it would be desiredto form the lower side wall 40 of the support structure 22 of a materialwhich blocks or at least substantially blocks a flow of blood. It mayalso be desired to have the upright (as viewed in FIG. 3) side walls 40of the retainer of support structure 22 formed of a material whichblocks or at least partially blocks a flow of blood. This constructionwould tend to promote the flow of blood from the lower portion of thesupport structure 22 to the upper portion of the support structure.

[0089] It is contemplated that the barrier 48 may be constructed of aplurality of members which are either interconnected or spaced apart tocause the blood to flow along a convoluted path between the arteriole 32and venule 34 of FIG. 3. The barrier 48 may be constructed with aplurality of bends which cause the blood to flow from the arteriole 32through a maze in the support structure 22 to promote the flow of bloodpast each of the viable cells 24. When the barrier 48 has such anextended irregular configuration, it may be desired to form the barrier48 of a material through which the blood can flow between various turnsand passages in the maze formed within the support structure 22. With apassage of time, it is believed that capillaries may tend to grow inmicron size passages in the support structure 22.

[0090] In the embodiments of the invention illustrated in FIGS. 1-3, thesupport structure 22 has been illustrated as having a polygonalconfiguration, specifically a rectangular configuration. However, it iscontemplated the support structure 22 could have a differentconfiguration if desired. For example, rather than the cubicleconfiguration illustrated in FIGS. 1-3, the support structure could havea configuration of a polyhedron with generally flat sides.Alternatively, the support structure 22 could have a spherical, oval, orovoid configuration. The specific configuration of the support structure22 is a function, in part at least, of a location where the supportstructure is to be positioned in a patient's body. Of course, theconfiguration of the side walls 40 of the support structure 22 will havean influence on the configuration on the barrier 48. It should beunderstood that the barrier 48 may have an arcuate configuration and maybe formed as a portion of a sphere or cylinder.

Alternative Implant

[0091] In the embodiments of the invention illustrated in FIGS. 1-3, thesame number of conduits are utilized to conduct blood to the implant asare used to conduct blood from the implant. Thus, a single arteriole 32and a single venule 34 are connected with a support structure 22 whichhas a relatively simple cubicle construction. A simple one piece barrier48 has been illustrated in FIG. 3 to direct a flow of blood within thesupport structure 22.

[0092] In the embodiment of the invention illustrated in FIG. 4, thenumber of conduits utilized to conduct blood to the implant is differentthan the number of conduits utilized to conduct blood from the implant.In addition, the implant 20 has a complex configuration formed by flatand arcuate surfaces. A multi-piece barrier is provided in the implantto direct the flow of blood.

[0093] In the embodiment of the implant 20 illustrated in FIG. 4, asingle arteriole 32 conducts a flow of blood to the support structure22. A plurality of venules 34 conduct the flow of blood from the supportstructure 22. Although only two venules 34 have been illustrated in FIG.4, it should be understood that a greater number of venules may beprovided if desired. Of course, a greater number of arterioles 32 couldalso be connected with the support structure 22 if desired. The numberof arterioles 32 may exceed the number of venules 34 if desired.

[0094] A plurality of viable cells 24 are provided within the supportstructure 22. A barrier 48 is provided within the support structure 22.In the embodiment of the invention illustrated in FIG. 4, the barrier 48is formed of a plurality of pieces or sections. One section 56 of thebarrier 48 has a generally conical configuration. However, the section56 of the barrier 48 has an open left (as viewed in FIG. 4) end portionto enable blood from the arteriole 32 to flow through the leftward endportion of the generally conical section 56 of the barrier. In addition,the barrier 48 includes a flow splitter 58 which disperses a flow ofblood entering the open left (as viewed in FIG. 4) end of the conicalsection 56 of the barrier. The flow splitter section 58 of the barriermay be formed by a plurality of pieces or by a single piece. The flowsplitter section 58 may be aligned with the opening in the left end ofthe barrier 48 or may be offset relative to the opening. For example,the splitter section 58 could be formed by a plurality of spaced apartsections each of which is offset slightly from the central axis of theopening formed in the left (as viewed in FIG. 4) end portion of thesection 56 of the barrier 48.

[0095] It should be understood that the arteriole 32 and venules 34 maybe connected with the support structure 22 of FIG. 4 in any one of themanners previously discussed herein. Rather than connecting an arteriole32 and venules 34 with the implant 20 as it is positioned in thepatient's body, conduits may extend from the support structure 22 and beconnected with one or more arteries and/or one or more veins in thepatient's body. It should be understood that either a greater or lessernumber of arterioles 32 and/or venules 34 may be connected with thesupport structure 22. The arterioles 32 and venules 34 may be connectedwith the support structure in any one of the manners previouslymentioned herein.

Organ Implant

[0096] It is contemplated that the implant 20 of FIGS. 1-4 may bepositioned in either soft or hard tissue in a patient's body. It isbelieved that it may be desired to position one or more of the implants20 in an organ in a patient's body. If this is done, the implant may beprovided with one or more side walls 40 having a configuration whichcorresponds to a configuration of the exterior surface of the organ.

[0097] Although it is contemplated that the implants 20 of FIGS. 1-4could be utilized in association of any one of the many different organsin a patient's body, the implants are described in conjunction with akidney 66 (FIG. 5) disposed in the patient's body. It should beunderstood that the kidney 66 is only an example of one specific organ,that is, a functional unit of cells, with which the implants of FIGS.1-4 may be associated.

[0098] The kidney 66 has a renal artery 68 through which blood isconducted to the kidney. In addition, the kidney 66 has a renal vein 70through which blood is conducted from the kidney. A ureter 72 conductsurine from the kidney 66 to the patient's bladder. The renal artery 68,renal vein 70 and ureter 72 are connected with a renal capsule 74.

[0099] When a kidney 66 becomes damaged by trauma and/or disease, it maybe desired to rejuvenate the kidney through the use of one or moreimplants corresponding to the implants 20 of FIGS. 1-4. The implants 20may be positioned in a spaced apart relationship in the kidney 66 orpositioned adjacent to each other. The specific location and arrangementof the implants 20 in the kidney 66 will depend upon the extent and typeof damage which the kidney has incurred.

[0100] The size and number of the implants positioned in the kidney 66,as well as their location in the kidney can be varied in the mannerbelieved to be the best remedy for damage to the kidney. For example, aplurality of the implants 20 (FIGS. 1-4) may be positioned at spacedapart locations in the kidney 66 (FIG. 6). Alternatively, the pluralityof the implants 20 may be positioned in engagement with each other atselected locations in the kidney 66. Since the implants 20 arerelatively small, the locations where they are positioned in the kidney66 can be selected to best compensate for the damage incurred by thekidney.

[0101] When a single implant 20 is to be positioned in the kidney, theimplant may be connected with blood vessels in the kidney in the mannerpreviously described in conjunction with FIGS. 1-4 herein.Alternatively, a plurality of the implants 20 may be connected in serieswith each other so that blood flows from one implant to the nextsucceeding implant. As was previously mentioned herein, the implants 20may be connected in parallel with each other and with an artery whichsupplies blood to the implants and a vein which receives the blood fromthe implants. As was also previously mentioned, the implants 20 may beassociated with any desired organ in the patient's body. The kidney 66of FIGS. 5 and 6 is only representative of many organs in a patient'sbody.

[0102] When an implant 20 is to be positioned in the kidney 66, a recessor opening having a configuration corresponding to the configuration ofthe implant is cut into the kidney. The implant 20 is then connectedwith blood vessels in the kidney 66 and is positioned in the opening(FIG. 6). The opening may be sized so as to accept a single implant 20or a plurality of implants. If the opening is sized to accept a singleimplant 20, the size of the single implant may be either relativelysmall or relatively large depending upon the damage which has beenoccurred by the kidney.

[0103] Under certain circumstances, it is believed that it may bedesired to remove a section, that is a relatively large piece of akidney. When this has been done, a single implant 20 having aconfiguration corresponding to the configuration of the removed sectionof the kidney may be implanted at the location where the section wasremoved from the kidney. Since the relatively large implant 20 has thesame configuration as the exterior surface of the kidney, when tissuegrows into the implant, the implant will form a portion of the kidneyhaving the same configuration as the section which was removed from thekidney.

[0104] When one or more implants 20 are to be positioned in the kidney66, the viable cells 24 may include renal cells having characteristicsof replaced cells in the kidney. Some of the viable cells in theimplants 20 may be stromal cells and/or fibroblast. Depending upon thelocation where the implants 20 are positioned in the kidney, some of theviable cells 24 may be endothelial cells. Thus, stromal cells, renalcells, and endothelial cells may be positioned on a single implant 20which is connected with the kidney 66. Of course, other types of cellsmay be positioned on the implant if desired.

[0105] Although the implants 20 have been illustrated in FIG. 6 as beingpositioned in the kidney 66, it is contemplated that the implants 20 maybe positioned in a different organ if desired. For example, the implants20 may be positioned in a patient's heart or one or more of the bones ofthe patient's skeleton. It is contemplated that the implants 20 may beused for applications other than partial or total organ replacement.Thus, the implant 20 may be located at any desired location in eitherhard or soft tissue in the patient's body.

Organ Replacement

[0106] It is contemplated that it may be desired to replace an entireorgan rather than a portion of the organ. When an organ is to bereplaced, a support structure 22 having a configuration corresponding tothe configuration the organ to be replaced is formed. This supportstructure 22 may be naturally formed or synthetically formed. The organto be replaced may be any one of the organs in the patient's body.

[0107] Assuming that the kidney 66 is the organ in a patient's body tobe replaced, it may be desired to form a support structure having aconfiguration corresponding to the configuration of the kidney 66. Whenit is desired to utilize a naturally formed support structure having theconfiguration of a kidney, a kidney 66 is obtained from a body. Thekidney 66 may be obtained from a patient's own body, from the body ofanother living human, from a cadaver (dead human body), or from a livingor dead animal.

[0108] When a kidney is used to form the support structure, it may bedesired to render the organ non-antigenic. Accordingly, any living cellson a kidney 66 removed from a living donor may be killed with acytotoxic solution, such as a strong saline solution. Alternatively, theliving cells may be killed by radiation. Of course, other methods couldbe utilized to kill the living cells.

[0109] Assuming that the kidney 66 is to be obtained from a cadaver, therenal artery 68, renal vein 70 and ureter 72 are severed and the kidney66 is removed from the cadaver. Dead cells and/or other tissue areremoved from the cadaver kidney to leave a collagen matrix having aconfiguration corresponding to the configuration of the kidney in thecadaver. The collagen matrix may have a relatively large portion with aconfiguration corresponding to the configuration of the renal capsule 74(FIG. 5), and three tubular conduits corresponding to the renal artery68, renal vein 70 and ureter 72.

[0110] The collagen matrix is utilized as a support structure 22 forviable cells, corresponding to the viable cells 24 of FIGS. 1-4. It iscontemplated that the viable cells 24 will be different types of cellsand will be placed at various locations in the collagen matrix formingthe support structure 22 made from the cadaver kidney. For example,renal cells may be positioned in the portion of the collagen matrixformed by the cadaver kidney corresponding to the renal capsule 74.Endothelial cells may also be positioned on the portion of the collagenmatrix corresponding to the renal capsule 74 and on the portions of thecollagen matrix corresponding to the renal artery 68, renal vein 70 andureter 72. In addition, stromal cells may be positioned on the portionof the collagen matrix corresponding to the renal capsule 74, renalartery 68, renal vein 70 and ureter 72. Fibroblast and mesenchymal cellsmay also be placed on the support structure 22 formed from the cadaverkidney. In addition, materials for promoting growth of tissue may bepositioned on the support structure.

[0111] Once the viable cells 24 have been positioned on the collagenmatrix support structure 22 formed from the cadaver kidney, the resultis a replacement kidney 66. The replacement kidney 66 may be formed at alocation spaced from an operating room. After the replacement kidney 66has been formed, it may be transported to the operating room andimplanted in the patient.

[0112] To implant the replacement kidney 66 in the patient, the damagedkidney in the patient is removed. Removal of the damaged kidney 66 fromthe patient would involve severing the renal artery 68, renal vein 70and ureter 72 connected with the damaged kidney in the patient.

[0113] After the damaged kidney 66 has been removed from the patient,the renal artery 68 of the replacement kidney is connected with theportion of the renal artery remaining in the patient's body. Similarly,the renal vein 70 of the replacement kidney 66 is connected with theportion of the renal vein remaining in the patient's body. In addition,the ureter 72 on the replacement kidney 66 is connected with the portionof the ureter remaining in the patient's body. The replacement kidney 66is then moved to a desired location in the patient's body.

[0114] Blood is conducted to the replacement kidney 66 through theremaining portion of the patient's renal artery 70 and the portion ofthe renal artery associated with the replacement kidney. Blood isconducted from the replacement kidney 66 through the portion of therenal vein 70 associated with the replacement kidney and the remainingportion of the patient's renal vein. Urine is conducted from thereplacement kidney 66 through the portion of the ureter 72 associatedwith the replacement kidney and to the remaining portion of thepatient's ureter.

[0115] Although the foregoing description has related to replacement ofa kidney 66, the method described herein may be used in association withthe replacement of the other organs in a patient's body. Thus, themethod described herein may be used in conjunction with the replacementof an adrenal gland, heart, liver, bone, pancreas, or other organ.

[0116] Rather than utilizing the collagen matrix of the cadaver kidneyto at least partially form the support structure for a replacementkidney, the cadaver kidney may be utilized as a pattern to form a moldcavity having a configuration corresponding to the configuration of thecadaver kidney. Thus, the cadaver kidney 66 (FIG. 7) may be enclosedwith mold material 80. The mold material may be divided into twosegments 82 and 84 (FIG. 7). The pattern 66 is enclosed by the moldmaterial 80 and the mold material is solidified around the pattern toform the two segments 82 and 84.

[0117] Once the mold material has solidified around the kidney pattern66, the kidney pattern is separated from the mold. Once the kidneypattern 66 has been separated from the mold 62, the two segments 82 and84 may be interconnected to form a mold assembly which defines a recessor cavity 88. The recess or cavity 88 has a configuration whichcorresponds to the configuration of the pattern kidney along with theattached portions of the renal artery 68, renal vein 70, and ureter 72.

[0118] The kidney pattern 66 may be obtained from a patient, fromanother living human, from a cadaver, or from an animal. It is believedthat it may be preferred not to use the patient's own kidney as thekidney pattern 66 since the configuration of the patient's ownkidney-may be unsuitable. If desired, an artificial pattern, having aconfiguration corresponding to a desired configuration of a kidney maybe used as a pattern for the mold cavity 88.

[0119] Once the mold cavity 88 has been formed by separating the moldsegments 82 and 84 from the natural or artificial kidney pattern 66, asynthetic support structure 22 is formed in the mold cavity 88. This maybe accomplished by injecting a material into the recess or cavity 88while the two mold segments 82 and 84 are interconnected. The materialinjected into the mold cavity 88 may be either biodegradable ornonbiodegradable. The material injected into the mold cavity 88solidifies with an open cell porous structure. Synthetic collagen orpolylatic acid with a chemical blowing agent or entrained gas may beutilized to form the porous support structure.

[0120] When the material injected into the mold cavity has solidifiedwith an open cell porous structure, it will have a configurationcorresponding to the configuration of the renal capsule 74 of the kidneypattern 66, the renal artery 68, renal vein 70 and ureter 72 connectedwith the renal capsule of the kidney pattern. The resulting supportstructure 22 is formed as one piece of porous material.

[0121] The selected viable cells, corresponding to viable cells 24(FIGS. 1-4), are positioned in small openings or pores of the castporous support structure 22 having the configuration of a kidney. It iscontemplated that the viable cells 24 may be positioned in any one ofmany different known ways on the porous support structure 22 having theconfiguration of a kidney. One way in which the viable cells may bepositioned on the porous support structure 22 is to inject a liquidsolution containing the viable cells 24 into the porous supportstructure 22. The viable cells 24 would be the deposited in the porousof the support structure 22 as the liquid dries. A different solutionwith different viable cells may be injected in different portions of theporous support structure 22. The viable cells 24 may be any of theviable cells previously mentioned herein. Of course, the viable cells 24would be deposited on the porous support structure 22 in accordance withthe desired tissue structure to be obtained by growth of the viablecells. Other known methods of positioning viable cells on a supportstructure may be utilized if desired.

[0122] Rather than forming a support structure 22 for the syntheticreplacement organ of a porous material, it is contemplated that thesupport structure may be formed of intertwined strands or filaments(FIG. 11). The strands or filaments may be woven together in the recessor cavity 88 formed by the mold segments 82 and 84. This would result inthe intertwined filaments or strands having an overall configurationcorresponding to the configuration of the pattern kidney 66 of FIG. 7.

[0123] The intertwined strands or filaments would define relativelysmall spaces in which the viable cells 24 would be positioned. Theviable cells 24 may be positioned on the woven support structure byinjecting a solution containing the viable cells into the spaces orrecesses formed by the intertwined strands of the support structure. Ofcourse, different types of viable cells 24 would be positioned atdifferent locations in the woven support structure. Any one of thedesired types of viable cells 24 previously mentioned herein may beutilized. It should be understood that the specific viable cells 24positioned at a specific location on the woven support structure 22would depend upon the desired characteristics of the tissue to be grownat that location.

[0124] The strands of the woven support structure 22 may be either anaturally occurring materials or synthetic materials. The strands of thewoven support structure 22 may be biodegradable or nonbiodegradable. Itis contemplated that strands of synthetic or natural collagen may beutilized to form the woven support structure 22 on which the viablecells 24 are positioned. If desired, the exterior of the woven supportstructure 22 may be sealed by encapsulating the woven support structurewith a material through which blood cannot easily flow. The materialused to encapsulate the woven support structure may be eitherbiodegradable or nonbiodegradable. It is contemplated that a suitablepolymeric material, such as polylatic acid, may be utilized. It isbelieved that blood vessels, such as capillaries, will grow throughsmall passages or channels formed in the woven support structure.

[0125] The foregoing description has been a conjunction with thereplacement of a kidney 66 in a patient. It is contemplated that theprocedures previously described herein could be utilized in conjunctionwith a replacement of many different types of organs. For example, apatient's pancreas may be replaced. If the patient's pancreas isreplaced, viable endocrine cells and viable exocrine cells may bepositioned on the support structure 22. In addition, islets ofLangerhans could be positioned on the support structure.

[0126] It is contemplated that the entire pancreas or only a portion ofthe pancreas may be replaced. If desired, relatively small implants,corresponding to the implants 20 of FIGS. 1-4, may be positioned in thepancreas. The specific types of viable cells, that is islets ofLangerhans, endocrine, and/or exocrine cells would be positioned at thelocation on the support structure 20 where the corresponding tissues areto be grown.

[0127] It is contemplated that a portion of the patient's hard tissue(bone) may be replaced using the foregoing methods. If this is to bedone, a support structure 22 having a configuration corresponding to aconfiguration of at least a portion of one of the bones in the patient'sskeleton would be replaced. The viable cells 24 positioned on thesupport structure 22 may be osteoblasts and/or mesodermal cells. Inaddition, osteochondral cells may be positioned on the support structure22. Myoblasts may be utilized in association with the support structure22 to promote the growth of muscular tissue.

Partial Replacement of an Organ

[0128] Rather than replacing an entire organ, it is contemplated that aportion of an organ may be replaced. In FIG. 8, a segment of a bloodvessel 96 is to be replaced. However, it should be understood that themethod of the present invention may be used to replace portions of anorgan other than a blood vessel. The segment of the blood vessel 96 hasbeen selected to be representative of a portion of many different organsin a patient's body.

[0129] When a segment of a blood vessel 96 is to be replaced, it isbelieved that the blood vessel will be severed at cuts 98 and 100disposed at spaced apart locations along the length of the blood vessel.The portion of the patient's blood vessel between the cuts 98 and 100 isremoved. An implant 104 is positioned between the cuts and connectedwith segments 106 and 108 of the blood vessel 96. The implant 104 istubular and has a cylindrical configuration.

[0130] The implant 104 includes a cylindrical support structure 112having the same general construction as the support structure 22 ofFIGS. 1-4. The support structure 112 has a plurality of openings orrecesses in which viable cells 114 are disposed. In the embodiment ofFIG. 8, the support structure 112 is enclosed by an outer layer 116which blocks a radially outward flow of blood from the inside of thetubular cylindrical implant 104.

[0131] The segments 106 and 108 of the blood vessel 96 may be connectedwith the support structure 112 by stitching or by adhesive. Of course,the support structure 112 could be connected with the segments 106 and108 of the blood vessel 96 in a different manner if desired.

[0132] It is contemplated that the viable cells 114 may includeendothelial cells, mesenchymal cells, and/or smooth muscle cells. Itshould be understood that more than one type of cell may be mounted onthe support structure 112. Tissue growth induction materials may beprovided on the support structure 112 to promote a growth of tissuebetween the segments 106 and 108 of the blood vessel 96 and the supportstructure 112. During a flow of blood through the blood vessel 96, theviable cells 114 on the support structure 112 are exposed to the flow ofblood.

[0133] If the blood vessel 96 is a vein, it may be desired to provide acheck valve in association with the implant 104. The check valve may beformed by flexible flaps which are pressed against each other to preventa back flow of blood in much the same way as in naturally occurringveins. The check valve may be formed by flaps of synthetic material orof a matrix of collagen or other materials in which viable smooth musclecells are disposed. If viable smooth muscle cells are provided on flapsformed of a support structure of natural or synthetic collagen or othermaterial, viable smooth muscle cells on the support structure 112 andthe smooth muscle cells on the check valve may grow together to providea check valve having the same general construction as a naturallyoccurring check valve in a vein or other organ.

[0134] Rather than being connected with a segment of a blood vessel, oneend of the implant 104 may be connected with another organ, such as aheart. Thus, the patient's blood vessel may be severed adjacent to theheart. The segment 106 of the blood vessel would be connected with oneaxial end portion of the support structure 112 of the implant 104. Theopposite axial end portion of the tubular cylindrical implant 104 wouldbe connected directly with the patient's heart. Of course, the implant104 could be associated with organs other than a patient's heart. Itshould also be understood that the implant 104 may be positioned in ablood vessel at a location remote from other organs.

[0135] During connection of the segments 106 and 108 of the blood vessel96 with the implant 104, it may be advantageous to utilize an expandablemember 122 to align the segments 106 and 108 of the blood vessel 96 withthe implant 104 in the manner illustrated schematically in FIG. 9. Whenthe expandable member 122 is in a contracted condition, it is insertedthrough a relatively small slit in the segment 108 of the blood vessel96 at a location remote from the cuts 98 and 100 where the implant 104is to be positioned. The expandable member 122 is moved axially alongthe blood vessel 96 to a location adjacent to the cut 100. While theexpandable member is in a contracted condition, it is moved from thesegment 108 of the blood vessel 96 into the implant 104. The leading endportion of the expandable member 122 is then moved from the implant 104into the segment 106 of the blood vessel 96.

[0136] Once the expandable member has been positioned so that it extendsbetween the segments 106 and 108 of the blood vessel 96 and through theimplant 104 (as shown in FIG. 9), the expandable member is expanded. Asthe expandable member 122 is expanded, the end portions of the segments106 and 108 of the blood vessel 96 adjacent to the implant are expandedand moved into alignment with the implant 104. As the expandable member122 expands radially outward from a contracted condition to the expandedcondition illustrated schematically in FIG. 9, a collapsed or contractedend portion of the segment 106 of the blood vessel 96 adjacent to thecut 98 is expanded. As this occurs, the end portion of the blood vesselsegment 106 adjacent to the cut 98 moves radially outward and is alignedwith an adjacent end portion of the cylindrical tubular implant 104. Atthe same time, the opposite end portion of the expandable member 122 isexpanded. As this occurs, the end portion of the segment 108 of theblood vessel 96 adjacent to the cut 100 is expanded. Thus, the endportion of the blood vessel 108 is expanded from a collapsed orcontracted condition to the expanded condition illustrated in FIG. 9 byexpansion of the expandable member 122.

[0137] As the expandable member 122 expands, a central portion of theexpandable member, that is a portion of the expandable member enclosedby the implant 104, expands into engagement with an inner side surfaceof the implant 104. As this occurs, annular axially opposite ends of theimplant 104 are aligned with the cuts 98 and 100 on the ends of theblood vessel segments 106 and 108.

[0138] While the blood vessel segments 106 and 108 are aligned with theimplant 104, the cut 98 on the end portion of the blood vessel 106 isconnected to the annular end portion of the implant 104. The segment 106of the blood vessel 96 may be connected with the implant 104 bystitching, by suitable adhesive, or by other known methods. Similarly,the cut 100 on the end portion of the segment 108 of the blood vessel 96is connected to the implant 104 by stitching, a suitable adhesive, orother known methods.

[0139] Once the blood vessel segments 106 and 108 have been connectedwith the implant 104, the expandable member 122 is contracted. Thecontracted expandable member 122 is then pulled out of the blood vessel96 through the same small opening through which the contractedexpandable member was moved into the blood vessel.

[0140] The expandable member 122 may be expanded by a mechanical deviceor by fluid pressure. Thus, the expandable member may have a devicewhich expands through a mechanical action in a manner similar to thatdisclosed in U.S. Pat. No. 5,685,826. Alternatively, the expandablemember 122 may be expanded under the influence of fluid pressure in themanner similar to that disclosed in U.S. Pat. No. 6,358,266. Theexpandable member 122 may be expanded in the manner similar to thatdisclosed in U.S. Pat. No. 6,338,730.

[0141] Although it is believed that many different types of knownexpandable devices may be utilized for the expandable member 122, theexpandable member may be a balloon which is expanded under the influenceof either gas or liquid pressure. The gas or liquid pressure may beconducted to the balloon through a conduit 128 (FIG. 9). The conduit 128may have sufficient rigidity so as to be able to move the expandablemember 122, specifically, a balloon, along the blood vessel 96 andthrough the implant 104 to the position illustrated schematically inFIG. 9 while the expandable member is in a contracted condition.

[0142] Once the expandable member has been expanded, under the influenceof fluid pressure conducted through the conduit 128, the implant 104 andsegments 106 and 108 of the blood vessel 96 are interconnected. Thefluid is then exhausted from the expandable member 122 through theconduit 128 to contract the expandable member. The contracted expandablemember is then pulled out of the blood vessel 96 under the influence offorce transmitted through the conduit 128.

[0143] Rather than using a single expandable member 122, a plurality ofexpandable members 134 and 136 (FIG. 10) may be utilized to align theimplants 104 and the end portions 106 and 108 of the blood vessel 96.The members 134 and 136 may be expanded by mechanical mechanisms or maybe expanded under the influence of fluid pressure in the mannerpreviously explained in conjunction with the expandable member 122 ofFIG. 9.

[0144] The expandable member 134 is inserted into the segment 106 of theblood vessel 96 when the expandable member is in a contracted condition.The contracted expandable member 134 is inserted through a small slitformed in the blood vessel 106 at a location spaced from the cut 98. Thecontracted expandable member 134 is pushed along the segment 106 of theblood vessel by a conduit 140 connected with the contracted expandablemember 134. The leading end portion of the contracted expandable member134 is moved from the segment 106 of the blood vessel 96 into theimplant 104.

[0145] Similarly, the contracted expandable member 136 is moved into thesegment 108 of the blood vessel 96 through a small slit at a locationspaced from the cut 100. The contracted expandable member 136 is pushedalong the segment 108 of the blood vessel 96 by a conduit 144. Theleading end portion of the contracted expandable member 136 is movedfrom the segment 108 of the blood vessel 96 into the implant 104.

[0146] After both of the contracted expandable members 134 and 136 havebeen position with their leading end portions in the implant 104, theyare expanded. Expansion of the expandable member 134 expands the endportion of the blood vessel segment 106 and moves it into alignment withthe adjacent end portions of the implant 104. Similarly, expansion ofthe expandable member 136 expands the end portion of the blood vesselsegment 108 and moves it into alignment with the end portion of theimplant 104. This results in the implant 104 and the segments 106 and108 of the blood vessel 96 being held in axial alignment with eachother, in the manner illustrated schematically in FIG. 10, by theexpanded expandable members 134 and 136.

[0147] While the implant 104 and segments 106 and 108 of the bloodvessel 96 are held in alignment by the expanded expandable members 134and 136, the end portions of the segments of the blood vessel areconnected with the implant 104. Thus, the annular cut end 98 of thesegment 106 to the blood vessel 96 is connected to one annular end ofthe implant 104. The annular cut end 100 of the blood vessel segment 108is connected to the opposite annular end of the implant 104. The bloodvessel segments 106 and 108 may be connected with the implant 104 bystitches, a suitable adhesive, or another known manner.

[0148] Once the blood vessel segments 106 and 108 have been connectedwith the implant 104, the expandable members 134 and 136 are contracted.The contracted expandable members 134 and 136 are then pulled from theblood vessel segments 106 and 108 through the small slits which theyenter the blood vessel segments.

[0149] Although the expandable members 134 and 136 may be mechanicallyexpandable members, it is believed that it may be preferred to expandthe expandable members under the influence of fluid pressure, that isunder the influence of pressure transmitted through either a gas or aliquid. The fluid pressure is conducted to the expandable members 134and 136 through the conduits 140 and 144.

[0150] In the embodiment of the invention illustrated in FIGS. 9 and 10,the expandable members 122, 134 and 136 are illustrated in conjunctionwith the connecting of segments 106 and 108 with a blood vessel 96 withan implant 104. However, it is contemplated that implant 104 could beconnected directly with an organ, such as a heart. For example, if theleft (as viewed in FIG. 9) end of the implant 104 is to be connectedwith a heart, the segment 106 of the blood vessel 96 would be omittedand the left or leading end portion of the balloon 122 (FIG. 9) insertedinto an opening formed in the heart. This would align the implant 104with the opening in the heart. The implant 104 would then be connecteddirectly to the heart with a suitable adhesive, stitching or other knowndevice. The segment 108 of the blood vessel 96 would then be connectedwith the implant 104 while the expandable member 122 maintains thesegment 108 of the blood vessel 96 in alignment with the implant 104.

[0151] Although the expandable members 122, 134 and 136 have previouslybeen described herein in conjunction with the connecting of an implant104 with at least one of the blood vessel segments 106 and/or 108, it iscontemplated that the expandable members may be utilized in thepositioning many different types of implants relative to many differenttypes of tissue. For example, expandable members similar to expandablemembers 122, 134 and 136 may be utilized in conjunction with theconnection of ducts with organs or with implanting of a segment in aduct. Alternatively, expandable members, similar to the expandablemembers 122, 134 and 136, may be utilized during the connection of animplant in a portion of a patient's intestine or during the connectionof an implant with one end of an intestine and a stomach.

[0152] It is contemplated that an implant may be positioned in a bone ina patient's body using expandable members similar to the expandablemembers 122, 134 and 136. This may be done by inserting an expandablemember through an opening in the implant. The expandable member wouldextend from the implant into the bone to align the bone with theimplant. Once the bone and the implant have been interconnected theexpandable member would be withdrawn from the opening through which itwas inserted into the implant. Once this has been accomplished, theinterior of the bone may be filled with an artificial cancellous bone orwith a slurry containing osteoblast and bone growth promoting materials.

Conclusion

[0153] In view of the foregoing description, it is apparent that thepresent invention provides a method of implanting viable cells 24 into abody of a patient. The viable cells 24 may be positioned on a supportstructure 22. One or more blood vessels 28 in a patient's body may beconnected with the support structure 22 at one or more locations. Theviable cells 24 on the support structure 22 may be exposed to blood flowin the support structure. One or more support structures 22 may beprovided and positioned in the patient's body.

[0154] The support structure 22 may be formed in many different ways.One way in which the support structure 22 may be formed is by removingan organ 66 or a portion of an organ from a body, either the patient'sown body or another body. Cells and/or other tissue may be removed fromthe organ 66 or portion of the organ to leave a support structure 22having a configuration corresponding to the configuration of the organor portion of an organ. Viable cells 24 are positioned on the supportstructure 22. The support structure 22, which has a configurationcorresponding to the configuration of an organ 66 or portion of anorgan, is positioned in the patient's body with the viable cells 24disposed on the support structure 22. Blood vessels 28 mayadvantageously be connected with the support structure 22 as it ispositioned in the patient's body. The support structure 22 maycorrespond to an entire organ 66 or only a portion of an organ.

[0155] The support structure 22 may be formed by using an organ 66 orportion of an organ from a body, that is either the patient's body oranother body, as a pattern. Alternatively, the pattern may besynthetically constructed to have a configuration corresponding to thegeneral configuration of an organ 66 or portion of an organ in apatient's body. The pattern is at least partially enclosed with moldmaterial 80. The pattern and mold material are subsequently separated toleave a mold cavity 88. The synthetic support structure 22 issubsequently shaped in the mold cavity 88. The synthetic supportstructure may be formed as a unitary member or formed by one or moreintertwined strands.

[0156] One or more expandable members 122, 134 and/or 136 may beutilized to align an implant 104 and tissue 96 in a patient's body. Forexample, one or more balloons may be utilized to align portions 106 and108 of a blood vessel with a segment 104 which is to be implanted intothe blood vessel.

[0157] It should be understood that the present invention has aplurality of different features which may be utilized separately or invarious combinations. It is also contemplated that the various featuresof the invention may be utilized with known features from the prior art.Although specific combination of features have been described herein, itis contemplated that other combinations of features will be apparent tothose skilled in the art and will be formed.

[0158] Furthermore, although certain applications are described herein,those of ordinary skill in the art will appreciate other applicationsfor the present invention. For example, the scaffold can be introducedwith a non-surgical procedure by a radiologist or other practitionerrather than a formal surgical procedure. The procedure could utilize MRIguidance (open, standing vertical, etc.), ultrasonic guidance, computernavigation, radiographic guidance, PET scanning. The MRI may be akinematic MRI to isolate the organ or MRI with external pressureallowing one to visualize the organ or tissue type specifically and thenimplant the scaffold under a pressurized approach so that the externalpressure applied would hold the organ in the position while the scaffoldwould be stabilized.

[0159] In view of the foregoing, it should be understood that variationsand modifications within the spirit and scope of the invention mightoccur to those skilled in the art to which the invention pertains.Accordingly, all expedient modifications readily attainable by oneversed in the art from the disclosure set forth herein that are withinthe scope and spirit of the present invention are to be included asfurther embodiments of the present invention. The scope of the presentinvention is accordingly defined as set forth in the appended claims.

Having described the invention, the following is claimed:
 1. A method ofimplanting cells into a body of a patient, said method comprising thesteps of providing a support structure, positioning viable cells on thesupport structure, connecting one portion of a blood vessel in thepatient's body with a first portion of the support structure, andconnecting another portion of a blood vessel in the patient's body witha second portion of the support structure.
 2. A method as set forth inclaim 1 further including the step of positioning the support structurein an organ in the body of the patient with the viable cells disposed onthe support structure.
 3. A method as set forth in claim 1 furtherincluding the step of conducting a flow of blood from the one portion ofa blood vessel in the patient's body through the support structure tothe other portion of the blood vessel in the patient's body.
 4. A methodas set forth in claim 1 wherein said step of connecting one portion of ablood vessel with a first portion of the support structure includesconnecting an artery with the first portion of the support structure,said step of connecting another portion of a blood vessel with a secondportion of the support structure includes connecting a vein with thesecond portion of the support structure.
 5. A method as set forth inclaim 1 wherein said step of connecting one portion of a blood vesselwith a first portion of the support structure includes connecting afirst portion of an artery with the first portion of the supportstructure, said step of connecting anther portion of a blood vessel witha second portion of the support structure includes connecting a secondportion of an artery with the second portion of the support structure.6. A method as set forth in claim 1 wherein said step of connecting oneportion of a blood vessel with a first portion of the support structureincludes connecting a first portion of a vein with the first portion ofthe support structure, said step of connecting another portion of ablood vessel with a second portion of the support structure includesconnecting a second portion of a vein with the second portion of thesupport structure.
 7. A method as set forth in claim 1 wherein said stepof connecting one portion of a blood vessel with a first portion of thesupport structure includes connecting a first blood vessel with thefirst portion of the support structure, said step of connecting anotherportion of a blood vessel with the second portion of the supportstructure includes connecting a second blood vessel with the secondportion of the support structure.
 8. A method as set forth in claim 1wherein said step of providing a support structure includes providing asupport structure with first and second conduits extending from thesupport structure, said step of connecting one portion of a blood vesselin the patient's body with the first portion of the support structureincludes connecting the first conduit with an artery in the patient'sbody, said step of connecting another portion of a blood vessel in thepatient's body with the second portion of the support structure includesconnecting the second conduit with a vein in the patient's body.
 9. Amethod as set forth in claim 1 wherein said step of providing a supportstructure includes providing a support structure with first and secondconduits extending from the support structure, said step of connectingone portion of a blood vessel in the patient's body with the firstportion of the support structure includes connecting the first conduitwith a portion of an artery in the patient's body, said step ofconnecting another portion of a blood vessel in the patient's bodyincludes connecting the second conduit with a portion of an artery inthe patient's body.
 10. A method as set forth in claim 1 wherein saidstep of providing a support structure includes providing a supportstructure with first and second conduits extending from the supportstructure, said step of connecting one portion of a blood vessel in thepatient's body with the first portion of the support structure includesconnecting the first conduit with a portion of a vein the patient'sbody, said step of connecting another portion of a blood vessel in thepatient's body with the second portion of the support structure includesconnecting the second conduit with a portion of a vein in the patient'sbody.
 11. A method as set forth in claim 1 wherein said step ofproviding a support structure includes providing a support structurewith first and second conduits extending from the support structure,said step of connecting one portion of a blood vessel in the patient'sbody with the first portion of the support structure includes connectingthe first conduit with a first blood vessel in the patient's body, saidstep of connecting another portion of a blood vessel in the patient'sbody with the second portion of the support structure includesconnecting the second conduit with a second blood vessel in thepatient's body.
 12. A method as set forth in claim 1 wherein said stepof providing a support structure includes providing a support structurewith first and second openings, said step of connecting one portion of ablood vessel in the patient's body with the first portion of the supportstructure includes moving the one portion of a blood vessel into thefirst opening, said step of connecting another portion of a blood vesselin the patient's body with the second portion of the support structureincludes moving the other portion of a blood vessel into the secondopening.
 13. A method as set forth in claim 12 further including thesteps of at least partially sealing a joint between the one portion of ablood vessel and the first opening, and at least partially sealing ajoint between the other portion of a blood vessel and the secondopening.
 14. A method as set forth in claim 1 wherein said step ofproviding a support structure includes providing a support structurewith first and second openings, said step of connecting one portion of ablood vessel in the patient's body with the first portion of the supportstructure includes moving a portion of an artery into the first opening,said step of connecting another portion of a blood vessel in thepatient's body with the second portion of the support structure includesmoving a portion of a vein into the second opening.
 15. A method as setforth in claim 14 further including the steps of at least partiallysealing a joint between the artery and the first opening, and at leastpartially sealing a joint between the vein and the second opening.
 16. Amethod as set forth in claim 1 wherein said step of providing a supportstructure includes providing a support structure with first and secondopenings, said step of connecting a portion of a blood vessel in apatient's body with the first portion of the support structure includesmoving a portion of an artery into the first opening, said step ofconnecting another portion of a blood vessel in the patient's body withthe second portion of the support structure includes moving a portion ofan artery into the second opening.
 17. A method as set forth in claim 1wherein said step of providing a support structure includes providing asupport structure with first and second openings, said step ofconnecting a portion of a blood vessel in a patient's body with thefirst portion of the support structure includes moving a portion of avein into the first opening, said step of connecting another portion ofa blood vessel in the patient's body with the second portion of thesupport structure includes moving a portion of a vein into the secondopening.
 18. A method as set forth in claim 1 wherein said steps ofconnecting one portion of a blood vessel in the patient's body with afirst portion of the support structure and connecting another portion ofa blood vessel in the patient's body with a second portion of thesupport structure are performed with the first and second portions ofthe support structure disposed on opposite sides of the supportstructure.
 19. A method as set forth in claim 1 wherein said steps ofconnecting one portion of a blood vessel in the patient's body with afirst portion of the support structure and connecting another portion ofa blood vessel in the patient's body with a second portion of thesupport structure are performed with the first and second portions ofthe support structure disposed on the same side of the supportstructure.
 20. A method as set forth in claim 1 wherein said step ofproviding a support structure includes providing a support structurecontaining a barrier, said method further includes directing blood flowfrom the first portion of the support structure to the second portion ofthe support structure along a nonlinear path with the barrier.
 21. Amethod as set forth in claim 1 wherein said step of providing a supportstructure includes providing a support structure with outer sides whichretard a flow of blood through the outer sides of the support structureduring a flow of blood through the support structure.
 22. A method asset forth in claim 1 further including the step of connecting a portionof a blood vessel in a patient's body with a third portion of thesupport structure, conducting a flow of blood to the support structurethrough the first portion of the support structure, conducting a flow ofblood from the support structure through the second portion of thesupport structure, and conducting a flow of blood either to or from thesupport structure through the third portion of the support structure.23. A method as set forth in claim 1 wherein said step of positioningviable cells on the support structure includes positioning viableprogenitor cells on a three dimensional support structure.
 24. A methodas set forth in claim 1 further including the steps of removing aportion of an organ from the patient's body, and connecting the supportstructure with the organ at a location where the portion of an organ wasremoved.
 25. A method as set forth in claim 1 wherein said step ofproviding a support structure includes providing a support structurehaving a surface area with a configuration corresponding to aconfiguration of a portion of a surface area of an organ in thepatient's body, removing a portion of the organ on which the portion ofa surface area of the organ is disposed, positioning the supportstructure in engagement with the organ at a location where the portionof the organ was removed, said step of positioning the support structurein engagement with the organ includes aligning the surface area on thesupport structure with a surface area on the organ.
 26. A method as setforth in claim 1 wherein said step of providing a support structureincludes removing an organ from a body, and removing cells from theorgan which is removed from the body to leave a support structure havinga configuration corresponding to the configuration of the organ, saidstep of positioning viable cells on the support structure includespositioning the viable cells on the support structure having aconfiguration corresponding to the configuration of the organ which isremoved from a body.
 27. A method as set forth in claim 26 wherein saidstep of removing an organ from a body includes removing the organ from acadaver.
 28. A method as set forth in claim 26 wherein said step ofremoving an organ from a body includes removing an organ from the bodyof the patient.
 29. A method as set forth in claim 26 wherein said stepof removing an organ from a body includes removing an organ from a bodyof a living human.
 30. A method as set forth in claim 26 wherein saidstep of removing an organ from a body includes removing an organ from abody of an animal.
 31. A method as set forth in claim 30 wherein saidstep of positioning viable cells on the support structure having aconfiguration corresponding to the configuration of the organ which isremoved from a body includes positioning a first type of viable cell ona first portion of the support structure and positioning a second typeof viable cell on a second portion of the support structure.
 32. Amethod as set forth in claim 31 wherein said step of positioning a firsttype of cell on a first portion of the support structure includespositioning endocrine cells on the first portion of the supportstructure and said step of positioning a second type of cell on a secondportion of the support structure includes positioning stromal cells onthe second portion of the support structure.
 33. A method as set forthin claim 31 wherein said step of positioning a first type of cell on afirst portion of the support structure includes positioning endothelialcells on the first portion of the support structure and said step ofpositioning a second type of cell on a second portion of the supportstructure includes positioning stromal cells on the second portion ofthe support structure.
 34. A method as set forth in claim 1 wherein saidstep of providing a support structure includes removing a portion of anorgan from a body, and removing cells from the portion of an organ whichis removed from the body to leave a support structure having aconfiguration corresponding to the configuration of the portion of anorgan, said step of positioning viable cells on the support structureincludes positioning the viable cells on the support structure having aconfiguration corresponding to the configuration of the portion of anorgan which is removed from a body.
 35. A method as set forth in claim34 wherein said step of removing a portion of an organ from a bodyincludes removing the portion of an organ from a cadaver.
 36. A methodas set forth in claim 34 wherein said step of removing a portion of anorgan from a body includes removing a portion of an organ from the bodyof the patient.
 37. A method as set forth in claim 34 wherein said stepof removing a portion of an organ from a body includes removing aportion of an organ from a body of a living human.
 38. A method as setforth in claim 34 wherein said step of removing a portion of an organfrom a body includes removing a portion of an organ from a body of ananimal.
 39. A method as set forth in claim 34 wherein said step ofpositioning viable cells on the support structure having a configurationcorresponding to the configuration of the portion of an organ which isremoved from a body includes positioning a first type of cell on a firstportion of the support structure and positioning a second type of cellon a second portion of the support structure.
 40. A method as set forthin claim 39 wherein said step of positioning a first type of cell on afirst portion of the support structure includes positioning endocrinecells on the first portion of the support structure and positioningstromal cells on the second portion of the support structure.
 41. Amethod as set forth in claim 39 wherein said step of positioning a firsttype of cell on a first portion of the support structure includespositioning endothelial cells on the first portion of the supportstructure and fibroblasts on the second portion of the supportstructure.
 42. A method as set forth in claim 1 wherein said step ofpositioning viable cells on the support structure includes positioningat least two different types of cells on the support structure.
 43. Amethod as set forth in claim 1 wherein said step of providing a supportstructure includes shaping the support structure to have a configurationcorresponding to a configuration of an organ in a human body.
 44. Amethod as set forth in claim 1 wherein said step of forming a supportstructure includes shaping the support structure to have a configurationcorresponding to a configuration of at least a portion of an organ in ahuman body.
 45. A method as set forth in claim 1 wherein said step ofproviding support structure includes spin molding the support structureto have a configuration corresponding to a configuration of at least aportion of an organ in a human body.
 46. A method as set forth in claim1 wherein said step of proving a support structure includes weaving athree dimensional support structure.
 47. A method as set forth in claim1 wherein said step of providing a support structure includes providinga pattern having a configuration corresponding to a configuration of atleast a portion of an organ in a human body, shaping mold materialagainst the pattern, separating the pattern and mold material to leave amold cavity, and shaping material in the mold cavity to form the supportstructure.
 48. A method as set forth in claim 1 wherein said step ofpositioning viable cells on the support structure includes positioningmesenchymal cells on the support structure.
 49. A method as set forth inclaim 1 wherein said step of positioning viable cells on the supportstructure includes positioning fetal cells on the support structure. 50.A method as set forth in claim 1 wherein said step of positioning viablecells on the support structure includes positioning embryonal cells onthe support structure.
 51. A method as set forth in claim 1 wherein saidstep of positioning viable cells on the support structure includespositioning endocrine cells on the support structure.
 52. A method asset forth in claim 1 wherein said step of positioning viable cells onthe support structure includes positioning stromal cells on the supportstructure.
 53. A method as set forth in claim 1 wherein said step ofpositioning viable cells on the support structure includes positioningfibroblasts on the support structure.
 54. A method as set forth in claim1 wherein said step of positioning viable cells on the support structureincludes positioning endothelial cells on the support structure.
 55. Amethod as set forth in claim 1 wherein said step of providing a supportstructure includes providing a tubular support structure, said step ofconnecting one portion of a blood vessel in the patient's body with afirst portion of the support structure includes connecting the oneportion of a blood vessel with a first end of the tubular supportstructure, said step of connecting another portion of a blood vessel inthe patient's body with a second portion of the support structureincludes connecting another portion of a blood vessel with a second endof the tubular support structure.
 56. A method as set forth in claim 55wherein said step of positioning viable cells on the support structureincludes positioning endothelial cells on the support structure.
 57. Amethod as set forth in claim 1 wherein said step of providing a supportstructure includes the step of providing a support structure formed of abiodegradable material.
 58. A method as set forth in claim 1 whereinsaid step of providing a support structure includes providing a supportstructure formed of a nonbiodegradable material.
 59. A method as setforth in claim 1 wherein said step of providing a support structureincludes providing a support structure formed of collagen.
 60. A methodas set forth in claim 1 wherein said step of positioning viable cells onthe support structure includes positioning osteoblast on the supportstructure.
 61. A method of implanting cells into a body of a patient,said method comprising the steps of providing a plurality of supportstructures, positioning viable cells on each of the support structures,forming a plurality of openings in an organ in the patient's body, andpositioning the plurality of support structures in the plurality ofopenings in the organ in the patient's body with the viable cellsdisposed on the support structures.
 62. A method as set forth in claim61 further including the step of connecting portions of blood vesselswith the support structures, said step of connecting portions of bloodvessels with the support structures includes connecting at least twoportions of one or more blood vessels with each of the supportstructures.
 63. A method as set forth in claim 62 wherein said step ofconnecting at least two portions of one or more blood vessels with eachof the support structures includes connecting a portion of an arterywith at least one of the support structures and connecting a portion ofa vein with at least the one of the support structures.
 64. A method asset forth in claim 62 wherein said step of connecting at lest twoportions of one or more blood vessels with each of the supportstructures includes connecting portions of one or more arteries with atleast one of the support structures.
 65. A method as set forth in claim62 wherein said step of connecting at least two portions of one or moreblood vessels with each of the support structures includes connectingportions of one or more veins with at least one of the supportstructures.
 66. A method of implanting cells into a body of a patient,said method comprising the steps of removing an organ from a body,removing cells from the organ which is removed from the body to leave asupport structure having a configuration corresponding to theconfiguration of the organ, positioning viable cells on the supportstructure having a configuration corresponding to the configuration ofthe organ which is removed from a body, and positioning the supportstructure in the patient's body with the viable cells disposed on thesupport structure.
 67. A method as set forth in claim 66 wherein saidstep of removing an organ from a body includes removing an organ from acadaver.
 68. A method as set forth in claim 66 wherein said step ofremoving an organ from a body includes removing an organ from the bodyof a patient.
 69. A method as set forth in claim 66 wherein said step ofremoving an organ from a body includes removing an organ from a body ofan animal.
 70. A method as set forth in claim 66 wherein said step ofremoving an organ from a body includes severing first and second bloodvessels connected with the organ, said step of positioning the supportstructure in the patient's body includes connecting one portion of ablood vessel in the patient's body with a portion of the first severedblood vessel connected with the organ and connecting another portion ofa blood vessel in the patient's body with a portion of the secondsevered blood vessel connected with the organ.
 71. A method as set forthin claim 66 wherein said step of positioning viable cells on the supportstructure having a configuration corresponding to a configuration of theorgan which is removed from a body includes positioning a first type ofviable cell on a first portion of the support structure and positioninga second type of viable cell on a second portion of the supportstructure.
 72. A method as set forth in claim 71 wherein said step ofpositioning a first type of cell on a first portion of the supportstructure includes positioning endocrine cells on the first portion ofthe support structure and positioning stromal cells on a second portionof the support structure.
 73. A method as set forth in claim 71 whereinsaid step of positioning a first type of cell on a first portion of thesupport structure includes positioning renal cells on the first portionof the support structure and said step of positioning a second type ofcell on a second portion of the support structure includes positioningstromal cells on the second portion of the support structure.
 74. Amethod as set forth in claim 71 wherein said step of positioning a firsttype of cell on a first portion of the support structure includespositioning endothelial cells on the first portion of the supportstructure and said step of positioning a second type of cell on a secondportion of the support structure includes positioning stromal cells onthe second portion of the support structure.
 75. A method as set forthin claim 66 wherein said step of positioning viable cells on the supportstructure includes positioning progenitor cells on the supportstructure.
 76. A method as set forth in claim 66 wherein said step ofpositioning viable cells on the support structure includes positioningendothelial cells on the support structure.
 77. A method as set forth inclaim 66 wherein said step of positioning viable cells on the supportstructure includes positioning fibroblasts on the support structure. 78.A method as set forth in claim 66 wherein said step of positioningviable cells on the support structure includes positioning stromal cellson the support structure.
 79. A method as set forth in claim 66 whereinsaid step of positioning viable cells on the support structure includespositioning endocrine cells on the support structure.
 80. A method asset forth in claim 66 wherein said step of positioning viable cells onthe support structure includes positioning embryonal cells on thesupport structure.
 81. A method as set forth in claim 66 wherein saidstep of positioning viable cells on the support structure includespositioning fetal cells on the support structure.
 82. A method as setforth in claim 66 wherein said step of positioning viable cells on thesupport structure includes positioning mesenchymal cells on the supportstructure.
 83. A method as set forth in claim 66 wherein said step ofremoving tissue from the organ includes removing cells from the organwhile at least partially maintaining a collagen matrix of the organ toleave a support structure which is at least partially formed of thecollagen matrix of the organ.
 84. A method as set forth in claim 66wherein said step of positioning the support structure in the patient'sbody includes connecting at least two portions of one or more bloodvessels with the support structure.
 85. A method as set forth in claim84 wherein said step of connecting at least two portions of one or moreblood vessels with the support structure includes connecting a portionof an artery with the support structure and connecting a portion of avein with the support structure.
 86. A method as set forth in claim 84wherein said step of connecting at least two portions of one or moreblood vessels with the support structure includes connecting a portionof one or more arteries with the support structure.
 87. A method as setforth in claim 84 wherein said step of connecting at least two portionsof one or more blood vessels with the support structure includesconnecting a portion of one or more veins with the support structure.88. A method as set forth in claim 66 wherein said step of removing anorgan from a body includes removing an organ from a cadaver.
 89. Amethod of implanting cells into a body of a patient, said methodcomprising the steps of removing a portion of an organ from a body,rendering the portion of an organ which is removed from the bodynon-antigenic to leave a support structure having a configurationcorresponding to the configuration of the portion of an organ,positioning viable cells on the support structure having a configurationcorresponding to the configuration of the portion of an organ which isremoved from a body, and positioning the support structure in thepatient's body with the viable cells disposed on the support structure.90. A method as set forth in claim 89 wherein said step of removing aportion of an organ from a body includes removing a portion of an organfrom a cadaver.
 91. A method a set forth in claim 89 wherein said stepof removing a portion of an organ from a body includes removing aportion of an organ from the body of the patient.
 92. A method as setforth in claim 89 wherein said step of removing a portion of an organfrom a body includes removing a portion of an organ from a body of ananimal.
 93. A method as set forth in claim 89 wherein said step ofremoving a portion of an organ from a body includes severing first andsecond blood vessels connected with the portion of an organ, said stepof positioning the support structure in the patient's body includesconnecting one portion of a blood vessel in the patient's body with aportion of the first severed blood vessel connected with the portion ofan organ and connecting another portion of a blood vessel in thepatient's body with a portion of the second severed blood vesselconnected with the portion of an organ.
 94. A method as set forth inclaim 89 wherein said step of positioning viable cells on the supportstructure having a configuration corresponding to a configuration of theportion of an organ which is removed from a body includes positioning afirst type of viable cell on a first portion of the support structureand positioning a second type of viable cell on a second portion of thesupport structure.
 95. A method as set forth in claim 94 wherein saidstep of positioning a first type of cell on a first portion of thesupport structure includes positioning endocrine cells on the firstportion of the support structure and positioning stromal cells on asecond portion of the support structure.
 96. A method a set forth inclaim 94 wherein said step of positioning a first type of cell on afirst portion of the support structure includes positioning renal cellson the first portion of the support structure and said step ofpositioning a second type of cell on a second portion of the supportstructure includes positioning stromal cells on the second portion ofthe support structure.
 97. A method as set forth in claim 94 whereinsaid step of positioning a first type of cell on a first portion of thesupport structure includes positioning endothelial cells on the firstportion of the support structure and said step of positioning a secondtype of cell on a second portion of the support structure includespositioning stromal cells on the second portion of the supportstructure.
 98. A method as set forth in claim 89 wherein said step ofpositioning viable cells on the support structure includes positioningprogenitor cells on the support structure.
 99. A method as set forth inclaim 89 wherein said step of positioning viable cells on the supportstructure includes positioning endothelial cells on the supportstructure.
 100. A method as set forth in claim 89 wherein said step ofpositioning viable cells on the support structure includes positioningfibroblasts on the support structure.
 101. A method as set forth inclaim 89 wherein said step of positioning viable cells on the supportstructure includes positioning stromal cells on the support structure.102. A method as set forth in claim 89 wherein said step of positioningviable cells on the support structure includes positioning endocrinecells on the support structure.
 103. A method as set forth in claim 89wherein said step of positioning viable cells on the support structureincludes positioning embryonal cells on the support structure.
 104. Amethod as set forth in claim 89 wherein said step of positioning viablecells on the support structure includes positioning fetal cells on thesupport structure.
 105. A method as set forth in claim 89 wherein saidstep of positioning viable cells on the support structure includespositioning mesenchymal cells on the support structure.
 106. A method asset forth in claim 89 wherein said step of removing cells from theportion of an organ includes removing cells from the portion of theorgan while at least partially maintaining a collagen matrix of theportion of an organ to leave a support structure which is at leastpartially formed of the collagen matrix of the portion of an organ. 107.A method as set forth in claim 89 wherein said step of positioning thesupport structure in the patient's body includes connecting at least twoportions of one or more blood vessels with the support structure.
 108. Amethod as set forth in claim 107 wherein said step of connecting atleast two portions of one or more blood vessels with the supportstructure includes connecting a portion of an artery with the supportstructure and connecting a portion of a vein with the support structure.109. A method as set forth in claim 107 wherein said step of connectingat least two portions of one or more blood vessels with the supportstructure includes connecting a portion of one or more arteries with thesupport structure.
 110. A method as set forth in claim 107 wherein saidstep of connecting at least two portions of one or more blood vesselswith the support structure includes connecting a portion of one or moreveins with the support structure.
 111. A method of implanting cells intoa body of a patient, said method comprising the steps of removing aportion of a blood vessel from the patient's body, providing a tubularsupport structure, positioning viable cells on the tubular supportstructure, connecting a first end portion of the tubular supportstructure with the blood vessel from which a portion was removed, andconducting a flow of blood between the tubular support structure and theblood vessel from which a portion was removed.
 112. A method as setforth in claim 111 further including the step of connecting a second endportion of the tubular support structure with tissue in the patient'sbody.
 113. A method as set forth in claim 112 wherein said steps ofconnecting a first end portion of the tubular support structure with theblood vessel and connecting a second end portion of the tubular supportstructure with tissue includes positioning an expandable member with afirst end portion of the expandable member enclosed by the blood vessel,a second end portion of the expandable member enclosed by the tissue,and a central portion of the expandable member enclosed by the tubularsupport structure, the central portion of the expandable member beingdisposed between the first and second end portions of the expandablemember.
 114. A method as set forth in claim 111 further including thestep of connecting a second end portion of the tubular support structurewith the blood vessel from which a portion was removed.
 115. A method asset forth in claim 114 wherein said step of connecting a first endportion of the tubular support structure with the blood vessel andconnecting a second end portion of the tubular support structure withthe blood vessel includes positioning a balloon with a first end portionof the balloon enclosed by the blood vessel, a second end portion of theballoon enclosed by the blood vessel, and a central portion of theballoon enclosed by the tubular support structure, the central portionof the balloon being disposed between the first and second end portionsof the balloon.
 116. A method as set forth in claim 111 wherein saidstep of connecting a first end portion of the tubular support structurewith the blood vessel includes positioning a balloon with a firstportion of the balloon enclosed by the blood vessel and a second portionof the balloon enclosed by the tubular support structure.
 117. A methodas set forth in claim 111 wherein said step of connecting the first endportion of the tubular support structure with the blood vessel includesaligning the blood vessel with the first end portion of the tubularsupport structure by applying force against an inner surface area on theblood vessel.
 118. A method as set forth in claim 117 wherein said stepof applying force against an inner surface area on the blood vesselincludes expanding an expandable member with at least a portion of theexpandable member disposed in the blood vessel.
 119. A method as setforth in claim 118 wherein said step of expanding a expandable member isperformed with a portion of the expandable member in the tubular supportstructure.
 120. A method as set forth in claim 111 wherein said step ofproviding a tubular support structure includes removing cells from theportion of the blood vessel removed from the patient's body to leave atubular support structure having a configuration corresponding to theconfiguration of the portion of the blood vessel removed from thepatient's body.
 121. A method as set forth in claim 120 wherein saidstep of removing cells from the portion of the blood vessel removed fromthe patient's body includes at least partially maintaining a collagenmatrix of the portion of the blood vessel to leave a tubular supportstructure which is at least partially formed of the collagen matrix ofthe portion of the blood vessel removed from the patient's body.
 122. Amethod as set forth in claim 111 wherein said step of positioning viablecells on the tubular support structure includes positioning endothelialcells on the tubular support structure.
 123. A method of implantingcells into a body of a patient, said method comprising the steps ofproviding a support structure containing a barrier, positioning viablecells on the support structure, positioning the support structure in thepatient's body with the viable cells disposed on the support structure,and directing a flow of blood through the support structure along anonlinear path with the barrier.
 124. A method as set forth in claim 123wherein said step of directing a flow of blood along a nonlinear pathwith the barrier includes conducting a flow of blood along oppositesides of the barrier.
 125. A method as set forth in claim 123 furtherincluding the steps of connecting one portion of a blood vessel in thepatient's body with a first portion of the support structure andconnecting another portion of a blood vessel in the patient's body witha second portion of the support structure, the barrier being at leastpartially disposed between the first and second portions of the supportstructure.
 126. A method as set forth in claim 123 wherein the barrierincludes a plurality of walls disposed within the support structure andthe flow of blood through the support structure is conducted alongsurfaces of the walls.
 127. A method as set forth in claim 123 furtherincluding the steps of connecting a first portion of a blood vessel inthe patient's body with a first portion of the support structure,connecting a second portion of a blood vessel in the patient's body witha second portion of the support structure, and connecting a thirdportion of a blood vessel in the patient's body with a third portion ofthe support structure, said step of directing a flow of blood throughthe support structure includes directing a flow of blood between thefirst, second and third portions of the support structure.
 128. A methodof implanting cells into a body of a patient, said method comprising thesteps of shaping a support structure to have an external configurationcorresponding to an external configuration of at least a portion of aselected organ, positioning viable cells on the support structure,removing at least a portion of the selected organ from the patient'sbody, and positioning the support structure in the patient's body at thelocation where at least a portion of the selected organ was removed fromthe patient's body.
 129. A method as set forth in claim 128 wherein saidstep of positioning the support structure in the patient's body includesconnecting a plurality of blood vessels with the support structure. 130.A method as set forth in claim 128 wherein said step of shaping asupport structure to have an external configuration corresponding to anexternal configuration of at least a portion of the selected organincludes providing a pattern having an external configuration of atleast a portion of the selected organ, forming a mold around at least aportion of the pattern, separating the mold and pattern to leave a moldcavity, and shaping material in the mold cavity to form the supportstructure.
 131. A method set forth in claim 130 wherein said step ofshaping material in the mold cavity to form the support structureincludes forming a porous support structure, said step of positioningviable cells on the support structure includes positioning viable cellsin the support structure.
 132. A method as set forth in claim 131wherein said step of positioning viable cells in the support structureincludes exposing the support structure to a liquid containing viablecells.
 133. A method as set forth in claim 130 wherein said step ofshaping material in the mold cavity to form the support structureincludes intertwining one or more strands in the mold cavity to at leastpartially form the support structure.
 134. A method as set forth inclaim 133 wherein said step of positioning viable cells on the supportstructure includes positioning the viable cells in openings formed byintertwining one or more strands in the mold cavity.
 135. A method asset forth in claim 134 wherein said step of positioning viable cells inopenings formed by intertwining one or more strands in the mold cavityincludes exposing the support structure to a liquid containing viablecells.